A Trial of a Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For Treatment of Atopic Dermatitis

NCT03000595 | Withdrawn Phase 2

• 1 other identifier: SAN007-03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial will be a double-blind, randomized, placebo-controlled, safety, tolerability and efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment regimen when administered daily for up to 28 days to patients from 3 months to 65 years of age, with atopic dermatitis.

Conditions

Atopic Dermatitis

Keywords

eczema

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.

  28 days

• Incidence of Irritation or Rash at the Site of Application of the Study Medication

  The percentage of patients reporting discomfort either during or immediately following the application of SAN007.

  28 Days

Secondary Outcomes (5)

• Percentage of Patients who Achieve an Improvement in Investigator Global Assessment Score

  28 Days

• Percentage of Patients who have a ≥ 25% reduction in the Eczema Area and Severity Index (EASI) score

  28 days

• Percentage of Patients who have a ≥ 50% reduction in the Eczema Area and Severity Index (EASI) score

  28 Days

• Percentage of patients achieving at least a 1-grade improvement in Investigator Global Assessment score

  28 Days

• Percentage of patients who have at least a 20% reduction in BSA affected by atopic dermatitis.

  28 Days

Study Arms (2)

SAN007 Cream

EXPERIMENTAL

A cream containing 5% East Indian sandalwood oil (EISO).

Drug: SAN007 Cream

Placebo

PLACEBO COMPARATOR

A placebo cream containing the same components as the vehicle for the active intervention arm

Drug: Placebo

Interventions

SAN007 Cream DRUG

A cream containing 5% East Indian sandalwood oil (EISO).

Also known as: Active

SAN007 Cream

Placebo DRUG

The vehicle cream

Also known as: SAN007 Placebo Cream

Placebo

Eligibility Criteria

• Age: 3 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 3 months of age
• Have atopic dermatitis, as determined by an EASI score of ≥5 and ≤50 (Hanifin, 2001)
• Total treatment area(s) of atopic dermatitis involvement ≥2% and ≤10% body surface area (BSA).
• Have atopic dermatitis that has been clinically stable for ≥ 1 month prior to the Screening Visit.
• Are able to obtain written informed consent/ascent in a manner approved by the Institutional Review Board and comply with the requirements of the study.
• Are willing to refrain from using any lotions, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the target treatment areas during the treatment period.
• Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
• Are willing to refrain from exposure to artificial ultraviolet radiation for the duration of the study.
• Are willing to cover target treatment areas to avoid exposure to natural ultraviolet radiation for the duration of the study.
• If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. i.e. barrier method, hormone or intrauterine device.
• Are willing to avoid participation in any other clinical trial for the duration of this study.
• Are willing to refrain from treating areas that are not the defined treatment area(s), which will be excluded from all assessments and BSA calculation.
• Are willing to refrain from treating study restricted areas. Study restricted areas are as follows: head, neck, soles of feet, palms of hands, axillae, or intertriginous areas.

You may not qualify if:

• Have a sibling or immediate family member already participating in this trial.
• Currently requires and/or, in the past month, has required topical use of a medium or high potency steroid.
• Atopic dermatitis that, in the opinion of the investigator, is likely to stem from an allergic reaction. (i.e. contact dermatitis)
• Have \<2% of atopic dermatitis involvement eligible for treatment.
• Have participated in any interventional clinical trial in the previous 30 days to the screening visit.
• Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances or any member of the Compositae family of vascular plants (e.g., sunflowers, daisies, dahlias, etc.).
• Have received phototherapy within the last 2 months prior to enrollment.
• Have received any systemic medication for atopic dermatitis in the past 2 months that would interfere with the evaluation of atopic dermatitis (excluding antihistamines or leukotriene inhibitors).
• Have a present condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• Are pregnant, breast-feeding or plan to become pregnant at any point for the duration of the trial.
• Are not willing to practice an approved form of birth control while on the study drug for the duration of the trial. i.e. barrier method, hormone or intrauterine device.
• Have been treated, with prescription medication for atopic dermatitis, with no improvement in condition, within 60 days prior to the Baseline visit.
• Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, or any other confounding skin condition.
• Have undergone treatments with topical atopic dermatitis drug products, other than retinoids or corticosteroids, within 14 days prior to the Baseline Visit, and for therapy containing corticosteroids or retinoids within 28 days prior to Baseline Visit.
• Have open sores or open lesions in the treatment area(s).

Sponsors & Collaborators

• Santalis Pharmaceuticals, Inc.: lead
• ClinDatrix, Inc.: collaborator
• Fremantle Dermatology: collaborator

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Exercise

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 22, 2016
• Study Start: June 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share